Table 1.
Inclusion/exclusion of pregnant women in clinical trials on COVID-19. See text of paper for trial identification methods. ∗In 1/146 of the trials, investigators declared the intention to revise the protocol if more than three pregnant women are excluded according to exclusion criteria. †In 6/36 of the trials, exclusion criteria related to pregnancy were not applicable, because of populations composed by children, older adults or post-menopausal women. ECMO, extra-corporeal membrane oxygenation; ECCO2R: extra-corporeal CO2 removal; SARS-CoV-2, severe acute respiratory syndrome coronavirus-2.
| Intervention | Trials, N | Purpose, N (%) | Participants, N | Pregnancy as exclusion criterion, N (%) | Specific gestational age as exclusion criterion, N (%) | Pregnant participants clearly defined as includable, N (%) | No specific information provided on pregnancy, N (%) |
|---|---|---|---|---|---|---|---|
| Drugs | |||||||
| Chloroquine or hydroxychloroquine | 39 | 18/39 (46%) Prophylaxis 18/39 (46%) Treatment 3/38 (8%) Treatment and prophylaxis |
147 105 | 25/39 (64) | 0/38 (0) | 1/39 (3) | 13/39 (33) |
| Anti-SARS-CoV-2 plasma or human immunoglobulin | 19 | 1/19 (5%) Prophylaxis 18/19 (95%) Treatment |
1958 | 7/19 (37) | 0/19 (0) | 0/19 (0) | 12/19 (63) |
| Antimalarials and azithromycin | 18 | 1/18 (6%) Prophylaxis 17/18 (94%) Treatment |
8581 | 14/18 (78) | 0/18 (0) | 0/18 (0) | 4/18 (22) |
| Stem cells or derivatives | 18 | 18/18 (100%) Treatment | 607 | 16/18 (89) | 0/18 (0) | 0/18 (0) | 2/18 (11) |
| Corticosteroids | 10 | 10/10 (100%) Treatment | 1476 | 10/10 (100) | 0/11 (0) | 0/11 (0) | 0/11 (0) |
| Tocilizumab | 7 | 7/7 (100%) Treatment | 1556 | 5/7 (71) | 0/7 (0) | 0/7 (0) | 2/7 (29) |
| Lopinavir/ritonavir | 3 | 2/3 (67%) Prophylaxis 1/3 (33%) Treatment |
2260 | 1/3 (33) | 0/3 (0) | 0/3 (0) | 2/3 (67) |
| Remdesivir | 3 | 3/3 (100%) Treatment | 4440 | 1/3 (33) | 0/3 (0) | 0/3 (0) | 2/3 (77) |
| Vaccines | 10 | 10/10 (100%) Prophylaxis | 7157 | 10/10 (100) | 0/10 (0) | 0/10 (0) | 0/10 (0) |
| Other drugs, combined treatments or multiple active comparators | 183 | 9/183 (5%) Prophylaxis 173/183 (94.5%) Treatment 1/183 (0.5%) Treatment and prophylaxis |
86 605 | 146/183 (80)∗ | 0/183 (0) | 0/183 (0) | 37/183 (20) |
| Overall | 310 | 41/310 (13%) Prophylaxis 265/310 (86%) Treatment 4/310 (1%) Treatment and prophylaxis |
261 745 | 235/310 (75.8) | 0/310 (0) | 1/310 (0.3) | 74/310 (23.9) |
| Non-pharmacological interventions | |||||||
| ECMO, ECCO2R, or CytoSorb therapy | 4 | 4/4 (100%) Treatment | 264 | 3/4 (75) | 0/4 (0) | 0/4 (0) | 1/4 (25) |
| Prone positioning or respiratory devices | 11 | 1/11 (9%) Prophylaxis 10/11 (91%) Treatment |
2497 | 4/11 (36) | 1/11 (9) | 0/11 (0) | 6/11 (55) |
| Other non-pharmacological interventions | 46 | 40/46 (87%) Other 6/46 (13%) Treatment |
47 889 | 9/46 (20) | 1/46 (2) | 0/46 (0) | 36/46 (78)† |
| Overall | 61 | 1/61 (1%) Prophylaxis 20/61 (33%) Treatment 40/61 (66%) Other |
50 650 | 16/61 (26) | 2/61 (3) | 0/61 (0) | 43/61 (71) |